QHRV 1 - HEALTH ASSESSMENT SYSTEM— 510(k) K080884
Substantially EquivalentMedtechs, LLC
FDA 510(k) clearance K080884 for QHRV 1 - HEALTH ASSESSMENT SYSTEM, Substantially Equivalent on 2008-04-11. Applicant: Medtechs, LLC.
Clearance details
- Applicant
- Medtechs, LLC
- Product code
- Code DPS
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Durhan, NC, US
Adverse events under product code DPS
product code DPS- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.